Recurrent gastric cancer with peritoneal dissemination
Conditions
Interventions
Oral administration of S-1 and intravenous and intraperitoneal administration of paclitaxel
Sponsors
Fujihara Yoshiyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients whose peritoneal dissemination was confirmed by image diagnosis or examination laparoscopy after radical resection (R0) for gastric adenocarcinoma. 2) Patients with following adequate function of important organs at screening period. a) Neutrocyte >= 1,000/mm3 b) Hemoglobin >= 8.0g/dl c) Platelet >= 75,000/mm3 d) AST, ALT = 30ml/min 3) ECOG PS with 0-2. 4) Age >= 20, < 85 years at consent form.
Exclusion criteria
Exclusion criteria: 1) Patinets with absence of metastasis to distant organ sites except ovary. 2) Patients who are contraindicated for S-1 or paclitaxel. 3) Patients with experience of using taxane anticancer drugs for unresectable/Recurrent gastric cancer. 4) Patients with peritoneal recurrence within 3 months after S-1 adjuvant chemotherapy. 5) Patients with concurrent double cancer at registration. 6) Patients with serious complications. 7) Patients with pregnancy, breast feeding or intention to become pregnant. 8) Patients who participated in other clinical studies within 3 months before registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| - Oveall survival - Overall survival rate - Time to treatment failure - Response rate - Peritoneal lavage cytology negative rate - Safety | — |
Contacts
Public ContactKozo Miyatani
Tottori University Hospital
Outcome results
None listed